The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
890
The intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.
Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
RECRUITINGThe primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.
based on VARC-3
Time frame: 5 years
Each of the individual components of the primary composite endpoint
based on VARC-3
Time frame: 5 years
Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia
VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no)
Time frame: 5 years
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)
BARC-based bleeding complications (qualitative ordinal variable; 3b-5)
Time frame: 5 years
New York Heart Association classification III or IV
New York Heart Association classification (qualitative variable; III or IV)
Time frame: 5 years
Health status evaluated by the Kansas City Cardiomyopathy Questionnaire
The KCCQ score, short for Kansas City Cardiomyopathy Questionnaire score, is a disease-specific, patient-reported score used to assess health status in heart failure. It consists of 23 items that assess symptoms, quality of life, and the impact of the disease on physical and social functioning over the past two weeks. Each area is transformed on a scale of 0 to 100, with higher scores indicating better health status. A difference of 5 points is considered clinically relevant, both for improvement and deterioration.
Time frame: 5 years
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Health status evaluated by the SF-36 questionnaire
The SF-36 measures 3 aspects of health (functional status, wellbeing, overall evaluation of health) using 8 separate scales. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions).
Time frame: 5 years
Six-minute walk test
six-minute walk test (quantitative continuous variable)
Time frame: 5 years
Treatment Costs per quality adjusted life year Assessment of Safety
This data will be collected for participating sites of countries in which this data is available. In patient costs will be measured through the collection of hospital billing and resource utilization information.
Time frame: 5 years